Senior Project Quality Systems Lead — Engineering Audits & CAPA

i-Pharm GxP; Richmond (VA); On-site; USD 140,000 - 180,000; Full time

Job summary

i-Pharm GxP is seeking a Project Quality Systems Lead to build and oversee the QMS for a multibillion-dollar capital project. You will translate complex regulatory and governance requirements into practical procedures for delivery teams across engineering, procurement, construction, commissioning and turnover.

The role requires 12+ years of QMS experience on major projects and a strong track record in engineering audits, CAPA and leading quality systems implementations.

Qualifications

• 12+ years of QMS experience on major projects in heavy industry, infrastructure, energy or a similar environment.
• At least 5 years in a Quality Manager or quality systems implementation lead role.
• Experience building and implementing a project QMS, with strong engineering audit and CAPA experience.
• Experience using AI assistants to analyse technical documents and support drafting, with good judgement around accuracy, confidentiality and document control.
• A degree in Engineering or Construction Management, and familiarity with systems engineering, root cause analysis and technical document management.

Responsibilities

• Develop and maintain the project QMS, including quality manuals, procedures and workflows.
• Turn project governance documents and regulatory requirements into practical processes for delivery teams.
• Plan and lead engineering quality audits across internal design teams and joint venture partners.
• Manage engineering nonconformances, root cause investigations and corrective and preventive actions through to closure.
• Track measures such as engineering completeness, design rework and audit findings, and report them to senior stakeholders.
• Use approved AI tools to support document review and procedure development, checking outputs against source documents and taking ownership of the final work.

Skills

Quality management

Audit leadership

CAPA

Regulatory compliance

Stakeholder communication

Education

Engineering or Construction Management degree

Tools

AI tools

Job description

i-Pharm GxP is seeking a Project Quality Systems Lead to build and oversee the QMS for a multibillion-dollar capital project. You will translate complex regulatory and governance requirements into practical procedures for delivery teams across engineering, procurement, construction, commissioning and turnover.

The role requires 12+ years of QMS experience on major projects and a strong track record in engineering audits, CAPA and leading quality systems implementations.